Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

Description

The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.

Conditions

Hematologic Malignancies

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Study Overview

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Study Details

Study overview

The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.

IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy

Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

Condition
Hematologic Malignancies
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient age \>/= 65 years
  • * Patient has a related donor who is a human leukocyte antigens (HLA) haploidentical match
  • * Patient and Donor sign the Informed Consent Form for the study
  • * Patient meets standard criteria for allogeneic stem cell transplant
  • * Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant
  • * Donor is willing to donate peripheral blood stem cells (PBSC)
  • * Patient has a diagnosis of myelofibrosis
  • * Patient has high titer antibodies (\>10,000 mean fluorescent intensity) against one or more donor HLA antigens
  • * Patient has undergone prior autologous or allogeneic stem cell transplant
  • * Inability to collect at least 3 x 10\^6 CD34+ PBSCs/kg recipient weight from the donor
  • * Requiring sedation for cardiac MRIs.
  • * Prohibited Implants and/or Devices:
  • * Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)
  • * Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • * Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ronald Paquette,

Ronald Paquette, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2028-07-01